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Process Support Engineer

m/w/d, Zug

Do you have first experience in pharmaceutical product development process management?

Then have a look into our clients Process Support Department - you and your 6 team members will be responsible for process guidance, process optimization and documentation of various development projects at our clients office in Rotkreuz (CH).

start date: 01.06.2024
end date: one year contract, with a high chance on extension
workload: 80 - 100%
location: Rotkreuz (CH)
work model: Contracting

Your Responsibilities:

Responsible for process guidance, process optimization and documentation of various development projects (system and assay) regarding Requirements- and Risk-Management, Configuration Management, Verification and Validation Management, and/or Usability Engineering
Support translation of multi-level requirements via Requirements Management process
Conduct detailed risk assessments by analyzing documents, statistics, reports and market trends and with a team of cross functional representatives
Ensure all risks and requirements are maintained within a database and streamline approach across project
Ensure the delivery of timely and good quality risk and requirements documentation
Establish and perform Configuration Management in complex development projects
Support development projects as Verification Manager (Planning, Guiding, Training, Reporting)
Managing project related interactions with Development, Global Platform Support, Design Quality Assurance, Regulatory, Medical Affairs, external suppliers and other internal departments.
Information gathering from respective stakeholders including consolidation of information
Ensure the delivery of timely and good quality documentation

Your Profile:

University degree in Life Sciences, Natural Sciences or Engineering
First experience and good technical understanding of product development processes within a highly regulated environment - preferred GMP regulated Diagnostics industry
Database experience is a strong plus
First work experience in Process Management (Risk-, Requirements-, Configuration-, Defect and/or Verification Management)
Good analytical thinking, a structured, reliable working manner
ability to prioritize, plan and manage multiple tasks and to instill a sense of urgency in teams
Excellent verbal and written communication skills in English, and preferably German in addition
Excellent communication and presentation skills